Endolumenal device for delivering and deploying an endolumenal expandable prosthesis

ABSTRACT

An endolumenal device ( 1 ) for delivering and deploying an endolumenal expandable prosthesis ( 6 ) at a bifurcation provided with a main conduit and at least a secondary conduit, comprises an elongated body ( 2 ) having a proximal end portion ( 4 ) and a distal end portion ( 3 ); the distal end portion ( 3 ) comprising expansion means ( 5 ) having a longitudinally extended active portion removably engageable with the prosthesis ( 6 ). Said active portion of the expansion means to longitudinally associated to the body in order to expand said prosthesis eccentrically from one side with respect to the body, in order to leave free from said expanded active portion the other side of the body. The device further is provided with guidewire tracking means ( 11 ).

DESCRIPTION

The subject of the present invention is an endolumenal device fordelivering and deploying an endolumenal expandable prosthesis. Inparticular, the present invention refers to a device for delivering anddeploying an endolumenal expandable prosthesis at a bifurcation providedwith a main conduit and at least a secondary conduit. Said devicecomprises an elongated body having a proximal end portion and a distalend portion. The distal end portion of said elongated body comprisesexpansion means having a longitudinally extended active portionremovably engageable with the endolumenal expandable prosthesis andadapted to adjust said prosthesis from a radially collapsed condition toa radially expanded condition. The device further comprises a guidewiretracking means at least partially extending along said elongated body.

As is known, devices of the type described above are used for deliveringand deploying, meaning in particular fitting or grafting, prostheses orstents endolumenally within conduit systems, such as for example vesselscarrying body fluids and, in particular, lumens in the bodies of humanbeings and animals. Said vessels for the transportation of fluids are,for example, arterial blood vessels, such as coronary, peripheral andcerebral arteries, veins or gastrointestinal tracts.

Using the abovementioned devices it is possible, for example, to deployendolumenal prostheses, or stents, in a vessel in which atheroscleroticstenoses, or plaque, has partially or completely occluded the lumen.Said prosthesis forms a radial support for the surrounding wall of thelumen and prevents it partially or completely occluding again, once ithas been dilated by the expansion means (balloon). These procedures arecarried out using known angioplasty techniques. Techniques of this typeare, for example, described in the publication “The New Manual ofInterventional Cardiology” edited by Mark Freed, Cindy Grines and RobertD. Safian, Division of Cardiology at William Beaumont Hospital, RoyalOak, Michigan; Physicians' Press 1996.

It is also known that the use of said techniques of angioplasty forpercutaneous revascularization is increasingly used as an alternative tostandard surgical procedures such as by-bass and thromboendoatherectomy.

Stent use, originally limited to cases of acute periproceduralcomplications following simple balloon angioplasty, such as dissection,thrombosis and acute occlusion, now applies also to elective treatmentof coronary and systemic atherosclerotic lesions.

The widespread use of these techniques is considerably limited by thesignificant difficulties presented by the known endolumenal devices whenthey are used on vascular ramifications or bifurcations of the system ofconduits (bifurcation lesions).

It is known that procedures on bifurcation lesions are frequentlysubject to failures and acute complications, because the known devicesmay cause occlusion of that branch of the bifurcation which operatesnear the segment of the lumen in which the prosthesis is fitted.

In particular, due to the activation of the expansion means in a firstbranch of the bifurcation, the atheromatous material of the plaques isprotruded and displaced until it obstructs the ostium of a second branchof the bifurcation, (a problem known as “snow-plow” or“plaque-shifting”).

Due to the abovementioned “snow-plow” or “plaque-shifting”, the ostiumand the lumen of the occluded branch must again be rendered accessible,or regained, by re-introducing a guidewire through a barrier consistingof the plaque previously protruded and displaced until it obstructed thelumen.

In other words, it is necessary, following the implanting of the firstprosthesis, to insert a second guidewire and a second prosthesis intothe occluded branch, passing through the mesh, or struts, of the firstprosthesis. Even when it is possible to regain access to the occludedbranch, the procedure becomes extremely lengthy and, in any case, theresults depend very much on the experience of the surgeon.

Where the above described bifurcation lesions are present it istherefore essential that the procedure is carried out in highlyqualified centres, fully equipped for cardiac surgery, that may becalled upon urgently in the case periprocedural complications or lack ofsuccess in dilating the lesion or regaining the ostium of the sidebranch.

Due to the abovementioned difficulties, the use of stents with widecells or apertures to allow the introduction of a guidewire into theside branch and the passage of a second stent has been proposed. Howeverthese wide cells can give rise to an increase in prolapse of plaquematerial through the meshes, or struts, and, therefore, to imperfectre-vascularization and increased probability of re-stenosis.

One alternative is the simultaneous use of two devices fitted withexpansion means for the simultaneous insertion of two stents in each ofthe branches of the bifurcation (paired or kissing devices), or of asingle bifurcated stent.

This known solution however is very bulky and difficult to manoeuvre andcan only be used in large vessels and in proximal segments of thearterial tree. In other words, it is impossible to use this knownsolution in peripheral branches, where the presence of atheroscleroticplaques is more common. Furthermore, in order to insert the known paireddevices it is necessary to use large-diameter guide-catheters. Saidlarge diameter guide-catheters induce an higher periprocedural risk. Inaddition, the greater bulk of the paired devices occludes the vesselduring insertion causing ischemia during the procedure and making itimpossible to inject an adeguate amount of contrast medium which isuseful for visualizing the path for the correct positioning, first ofthe guidewire and then of the endolumenal devices fitted with theprosthesis.

The use of paired devices also lacks versatility, above all in the caseof a single bifurcated stent, since the three vascular segments whichmake up the bifurcation—the proximal main vessel, the main vessel distalto the bifurcation and the secondary vessel, or side branch—may be ofvery different bores with lesions of varying lengths. It is thereforeimpossible at present to prepare a range of bifurcated stents which canbe adapted to all the possible anatomical and pathological variables. Itmust also be noted that these bifurcated stents, of fixed dimensions,often occlude other branches near the bifurcation lesions, withconsequent ischemia or incomplete revascularization.

It is therefore evident that not all bifurcation lesions, and inparticular coronary bifurcation lesions, can be dealt withpercutaneously.

The above considerations show that the need for an endolumenal devicefor delivering and deploying an endolumenal expandable prosthesis, whichcan reach both the branches of a bifurcation safely and rapidly, iswidely felt.

Devices of this type are known from EP 0 897 700, WO 98 36709 and WO 9915103.

A need is likewise felt to be able to fit endolumenal prostheses whichare morphologically adaptable to the anatomy and to the pathology of theproximal and distal portions of the branches of the bifurcation. Inother words, it is desirable to be able to deal with all types oflesions using a single endolumenal device, of the type described above,capable of adapting to a vast range of vessel diameters and lesions ofany length. Said endolumenal device must also ensure the accuratedeployment of the prosthesis, guaranteeing wide coverage of thebifurcation, which prevents protrusion of plaque material between thevarious prostheses fitted and the formation of re-stenosis.

Therefore, the object of this invention is to devise and make availablean endolumenal device of the type specified above, which will meet allthe abovementioned requirements and, at the same time, make it possibleto avoid all the pitfalls outlined.

This object is achieved by means of an endolumenal device for deliveringand deploying an endolumenal expandable prosthesis at a bifurcationprovided with a main conduit and at least a secondary conduit,comprising an elongated body having a proximal end portion and a distalend portion; the distal end portion of said elongated body comprisingexpansion means having a longitudinally extended active portionremovably engageable with the endolumenal expandable prosthesis andadapted to adjust said prosthesis from a radially collapsed condition toa radially expanded condition; a guidewire tracking means at leastpartially extending along said elongated body. Said device ischaracterised by the fact that said active portion of the expansionmeans is longitudinally associated to the elongated body in order toexpand said prosthesis eccentrically from one side with respect to theelongated body, in order to leave free from said expanded active portionthe other side of the elongated body, and in that—said guidewiretracking means comprises at least a guidewire lumen at least partiallyextending inside said elongated body, having at least a guidewire distalport provided on a side of the elongated body opposed to the expansionmeans and suitable for slipping through it a guidewire portion of atleast a guidewire placeable with its distal portion in said main or atleast a secondary conduit.

The subject of the present invention also includes a method forassembling out of an human body said endolumenal device to guidewires,said guidewires being positioned along a common proximal section of pathand a diverging distal section of path, forming a bifurcation betweensaid sections, employing the following stages:

-   -   said endolumenal device is fitted onto a proximal end of a first        guidewire so that said first guidewire is received in a        guidewire lumen through a first distal guidewire port;    -   said endolumenal device is fitted onto a proximal end of a        second guidewire so that said second guidewire is received in        the guidewire lumen through a second distal guidewire port;    -   said endolumenal device is advanced along said guidewires until        at least part of the distal end portion of the elongated body is        positioned beyond the bifurcation of the guidewires.

The subject of the present invention also includes a method forassembling out of an human body said endolumenal device to guidewires,said guidewires being positioned along a common proximal section and adiverging distal section of path, forming a bifurcation between saidsections, employing the following stages:

-   -   said endolumenal device is fitted onto a proximal end of a first        guidewire so that said first guidewire is received in a        guidewire lumen through a first distal guidewire port;    -   said endolumenal device is fitted onto a proximal end of a        second guidewire so that said second guidewire is received in        the guidewire lumen through a second distal guidewire port;    -   said endolumenal device is advanced along said guidewires until        at least part of the distal end portion of the elongated body is        positioned on a distal diverging section of path of one of the        guidewires.

Further characteristics and advantages of the endolumenal deviceaccording to the invention will become evident from the description thatfollows of some preferred embodiments, which are given purely by way ofindication and without implying any limitation, with reference to theenclosed drawings, in which:

-   -   FIG. 1 shows a partially sectioned view of the endolumenal        device fitted with a prosthesis;    -   FIGS. 2 and 3 show a view from beneath, and a side view, of a        detail of the device of FIG. 1;    -   FIGS. 4 and 4 a show the enlarged cross section on IV-IV of the        device of FIG. 2, according to two embodiments;    -   FIG. 5 shows an end view along the arrow V of the endolumenal        device of FIG. 3;    -   FIGS. 6 a and 6 b show a partially sectioned view of the device        of FIG. 1 during two stages of use;    -   FIGS. 7 and 8 show a view from beneath, and a side view, of a        detail of an endolumenal device according to a second        embodiment;    -   FIG. 9 shows the enlarged cross section on IX-IX of the device        of FIG. 7;    -   FIG. 10 shows a front view along the arrow X of the device of        FIG. 8;    -   FIGS. 11 a and 11 b show a partially sectioned perspective view        of the device of FIG. 7 during two stages of use;    -   FIGS. 12 to 17 c show a section through a ‘T bifurcation’ during        eight stages in the deploying of endolumenal prostheses;    -   FIGS. 17 d and 17 e show in section two alternative stages in        the deploying of prostheses in the bifurcation shown in FIG. 17        c;    -   FIGS. 18 to 23 show a cross portion through a ‘Y bifurcation’        during six stages in the deploying of endolumenal prostheses;    -   FIGS. 24 and 25 show a view from beneath, and a side view, of an        endolumenal device provided with two distal ports at the distal        end of the body beyond the prosthesis;    -   FIG. 26 shows an enlarged section on XXVI-XXVI through the        device of FIG. 24;    -   FIG. 27 shows a view along the arrow XXVII of the device of FIG.        25;    -   FIGS. 28 and 29 show a view from beneath, and a side view        partially sectioned, of details of an endolumenal device having        a single guidewire lumen associated to distal ports at the        distal end of the body beyond the prosthesis;    -   FIG. 30 shows a view along the arrow XXX of the device of FIG.        29;    -   FIGS. 31 and 32 show a view from beneath, and a side view        partially sectioned, of details of an endolumenal device having        a plurality of guidewire lumens associated to a plurality of        distal ports;    -   FIGS. 33 and 34 show a perspective view and a side view, in        partial section, of an endolumenal device having a single        guidewire lumen associated to an apical distal port and a        plurality of distal ports spaced out along the body;    -   FIGS. 35 and 36 show a view from beneath, and a side view        partially sectioned, of details of an endolumenal device having        a first guidewire lumen associated to an apical distal port and        a second guidewire lumen associated to a plurality of distal        ports spaced out along the body;    -   FIGS. 37, 38 and 39 show a view from beneath, and a side view        partially sectioned, and an enlarged sectioned prospective of        details of an endolumenal device having a fissure suitable for        realising a distal port;    -   FIG. 40 shows a perspective view, partially sectioned, during a        stage in the slipping of a guidewire proximal end into the body        fissure of the device of FIG. 38;    -   FIGS. 41 to 45 show a cross portion through a vessel during five        stages in the deploying of an embolization containment device        and of an endolumenal prosthesis;    -   FIG. 42 c shows a detail in an enlarged scale of FIG. 42 a;    -   FIG. 42 b shows a cross portion through a vessel during a stages        in the deploying of an embolization containment device according        to a further embodiment;    -   FIG. 46 to 51 show a cross portion through a bifurcation during        six stages in the deploying of embolization containment devices        and of an endolumenal prosthesis;    -   FIG. 52 shows a cross portion through the coronary ostium during        a stage in the deploying of an endolumenal prosthesis;    -   FIG. 53 to 55 show a cross portion through a bifurcation during        three stages in the deploying of endolumenal prostheses by means        of two endolumenal devices reciprocally connected through a        guidewire;    -   FIG. 56 shows a perspective view, partially sectioned, of an        endolumenal device wearing a stent provided with a        differentiated spatial behaviour.

With reference to the above figures, the number 1 indicates as a wholean endolumenal device for delivering and deploying an endolumenalexpandable prosthesis, or balloon catheter. For example, said device issuitable for deploying an endolumenal expandable prosthesis at abifurcation provided with a main conduit and at least a secondaryconduit. The endolumenal device includes an elongated body 2 having adistal end portion 3 and a proximal end portion 4. For example, saidelongated body 2 is between 100 cm and 160 cm in length, and preferablybetween 115 cm and 140 cm. The distal end portion 3 includes expansionmeans, 5, which can be removably engaged with an endolumenal expandableprosthesis 6. Said expansion means 5 can adapt said prosthesis 6 from aradially collapsed to a radially expanded position, in a manner whichwill be described in greater detail below. The expansion means 5 includea distal portion 7 of the expansion means a proximal portion 8 of theexpansion means and a central portion 5 a of the expansion means towhich the prosthesis 6 can be attached. The distal portion of theelongated body 3 extends beyond the expansion means 5 in an apicalportion 9. At the proximal end of the proximal end portion 4 of theelongated body 2, there are means 10 for connecting the endolumenaldevice 1 to an apparatus of a type known per se for the controlledactivation of the expansion means 5. The endolumenal device 1 alsoincludes guidewire tracking means 11 which extend at least partiallyalong the elongated body 2. For example, said means 11 extend along thedistal end portion 3 of the elongated body 2 close to the expansionmeans, 5 (FIG. 1).

Advantageously, the active portion of the expansion means islongitudinally associated to the elongated body in order to expand saidprosthesis eccentrically from one side with respect to the elongatedbody, in order to leave free from said expanded active portion the otherside of the elongated body.

With further advantage, the guidewire tracking means 11 comprises atleast a guidewire lumen 12 or 13 that at least partially extends insidesaid elongated body 2. Said lumen has at least a guidewire distal port15 provided on a side of the elongated body opposed to the expansionmeans and suitable for slipping through it a guidewire portion of atleast a guidewire placeable with its distal portion in a main or atleast a secondary conduit.

In one embodiment of the invention, a first guidewire lumen 12 and asecond guidewire lumen 13 extend completely inside the elongated body 2.Distal ports 14, 15 and proximal ports 16, 17 make said first and secondlumens 12, 13 able to receive guidewires 24, 25 (FIG. 19).

The distal ports 14, 15 are preferably spaced out along the elongatedbody 2. For example, the distal port 14 of the first guidewire lumen 12is provided at the distal end of the apical portion 9, and the distalport 15 of the second guidewire lumen 13 is provided near the distal endof the expansion means 5 (FIGS. 1-3, 6 a, 6 b, 18-23). The proximalports 16, 17 are preferably positioned in the portion of the elongatedbody 2 that lies between its proximal end and the expansion means 5. Forexample, said ports 16, 17 are located at a distance ranging between 90cm and 130 cm, and preferably, between 105 cm and 115 cm, from theproximal end, or from the connector means 10 (FIG. 1).

According to one embodiment, said endolumenal device is a ballooncatheter for angioplasty, 1. Said balloon catheter 1 comprises a tubularcatheter 2, a proximal connector 10, and an inflatable balloon 5.

The catheter body 2 is tubular. The proximal portion 4 of said tubularbody 2 is designed to support and push the distal portion 3. Thereforesaid proximal portion 4 is less flexible than the distal portion, whichmust be flexible in order to be able to enter the peripheral branches ofa vessel. For example, said proximal portion 4 is made of abiocompatible material, such as biomedical steel or nylon™. Moreover,said proximal portion 4 is designed to be received in a guide catheter(not shown and known per se) which is necessary for maintainingaccessibility of the lumen of the vessel on which it is necessary tooperate even when the endolumenal device 1 is withdrawn. Said guidecatheter is also necessary for introducing, for example, a radio-opaquecontrast medium into the vessel. The proximal portion 4 of the catheterbody, 2 includes an inflation lumen, 18 (FIGS. 3, 4 and 4 a, 6 b). Saidlumen 18 extends from the proximal end of the catheter body 2 to theinflatable balloon 5.

The proximal connector, 10, for example a connector commonly known as a“Luer”, is provided at the proximal end of said portion 4 and forms theabovementioned means of connection of the endolumenal device 1 to theapparatus for the controlled activation of the balloon 5. For example,said connector connects the inflation lumen 18 of the balloon 5 to apressurized fluid source.

The balloon 5 is associated with the distal portion 3 of the catheterbody 2 to form an inflation chamber 19 which at least partiallysurrounds the catheter body (FIG. 3). The inflation chamber 19 isdelimited by a balloon wall 20 equipped with an external envelope 22.Said inflation chamber 19 is in communication with the inflation lumen18. In one embodiment, the balloon includes, between a distal portion 7and a proximal portion 8, a central portion 5 a. Said central portion 5a, when it is in a radially expanded, or inflated position, is roughlycylindrical. The balloon wall 20 in one embodiment is non-extendable orrigid when subjected to pressurized fluid. Therefore the balloon wall20, when it is in a radially collapsed position, is folded around thecatheter body 2, for example it is threefolded or, in other words, formsthree folds 21 (FIG. 6 a). By means of the external envelope 22, theballoon wall 20 can be removably fitted with an endolumenal prosthesis.For example, the external envelope is removably fitted with anendovascular stent, plastically deformable from a radially collapsedcondition to a radially expanded condition, which can be fixed bypressure to the internal surface of a vessel wall. For example, saidstent is a metallic tubular stent comprising struts or mesh. For thisreason, the diameter of the central cylindrical portion 5 a, when theballoon is radially expanded or inflated by pressurized fluid injectedthrough the inflation lumen 18, is such as to fix said prosthesis to thewall of the vessel by pressure (FIG. 6 b).

In a preferred embodiment of the invention, a longitudinal portion ofthe balloon wall 20 is associated internally with the catheter body 2.In other words, said wall 20 is fixed along its entire length to thecatheter body, so that when the balloon 5 changes from the radiallycollapsed or deflated position to the radially expanded or inflatedposition, said balloon 5 will extend eccentrically or asymmetricallywith respect to the catheter body 2, or in other words, on only one sideof the body (FIGS. 3, 5 and 6 b).

The distal portion 7 and the proximal portion 8 of the balloon 5 areadvantageously tapered in shape. In particular, said portions aretruncated cones.

Advantageously, the tubular catheter body 2 comprises sheath means orsleeve means 23, for example a flexible conduit. For example, saidsheath means are an integral part of the elongated body. The sheathmeans 23 include a tubular body through which run a number oflongitudinal lumens, 12, 13 forming the abovementioned guidewire lumens.The guidewire lumens 13, 14, or sections of these, advantageously run inparallel along the elongated body. Said lumens debouch at theextremities of the sheath means with the abovementioned guidewire ports14, 15, 16, 17. Said sheath means 23 are located inside the tubularcatheter body 2 in such a way as to leave a space (which forms theabovementioned inflation lumen 18) along the entire length of thatportion of the catheter body 2 which is situated between the proximalconnector 10 and the balloon 5. Preferably, said sheath means areattached for their entire length to the portion of the wall delimitingthe balloon inflation chamber (FIGS. 3, 4, 4 a and 6 b). In other words,where the tubular elongated body of the catheter continues in theballoon wall, said sheath means are associated to a portion of theballoon wall. In one embodiment, said sheath means extend beside theballoon distal portion becoming said catheter body apical portion. Theextremities of the sheath means 23 are attached to the wall of thecatheter body in such a way as to make the guidewire lumens accessiblefrom outside the catheter body through the guidewire ports.

It is particularly advantageous when said sheath means 23 debouch in afirst distal guidewire port 14, of a first guidewire lumen 12, distantfrom a second distal guidewire port 15 of a second guidewire lumen 13.

In particular, said sheath means extend to the tip of the distal portion3 of the catheter body 2 in such a way as to debouch with the firstdistal guidewire port to the tip of the apical tract 9.

In a first embodiment of the invention, thanks to the asymmetricalposition of the balloon 5 with respect to the catheter body 2, thesecond distal guidewire port 15 is positioned along the catheter body 2so as to allow the second guidewire lumen 13 to debouch at the distalend of the central portion 5 a of the balloon, or in other words, so asto be positioned just outside the prosthesis 6 attachable to the balloon5 (FIGS. 1 to 6 b).

In a second embodiment of the invention, the second distal guidewireport 15 is positioned along the catheter body in such a way that thesecond guidewire lumen 13 debouches at a point located between thedistal portion 7 and the proximal portion 8 of the balloon 5, and inparticular at a point of the central portion 5 a attachable to theprosthesis 6. For example, said port 15 is located near the centre lineof said central portion 5 a (FIGS. 7, 8, 11 a and 11 b). Preferably, theprosthesis 6, which can be attached to said catheter 1, has a window 26designed to prevent obstruction of said distal guidewire port 15 when itis fitted on the balloon 5. For example, the prosthesis 6 has a widercell 26 than the other cells of the prosthesis, and at the same time ofa size close to that of the ostium of the lumen of the branch on whichit is necessary to proceed, or only slightly smaller. Alternatively, theballoon can be fitted with a number of prostheses, placed side by sidein order to avoid obstructing said port 15.

Preferably, the proximal guidewire ports 16, 17 are located in a portionof the catheter body 2 which, during use of the catheter 1, remainssheathed in the guide-catheter. For example, said proximal guidewireports are located at a distance from the tip of the catheter rangingbetween 15 cm and 35 cm and, preferably between 20 cm and 30 cm.Alternatively, said ports 16, 17 are located at the proximal end of thecatheter body. In this case the balloon catheter 1 is fitted with aproximal connector 10 with at least two channels. A channel for theadmission of the pressurized fluid into the inflation lumen 18, andchannels for passing the guidewires 24, 25 along.

Advantageously, radio-opaque markers, 30 and 31 are associated with thecatheter body 2 (FIG. 3). For example, said markers are located alongthe catheter body 2 at the distal and proximal ends of the prosthesis 6.

Said catheter body also includes radio-opaque markers for theidentification of the position along said body of the distal 14, 15,and/or proximal 16, 17 guidewire ports of the guidewire lumens 13, 14.

The subject of the present invention also comprises a kit for deliveringand deploying an endolumenal expandable prosthesis. Said kit comprisesan endolumenal device, 1, as described above, at least a couple ofguidewires 24, 25, and at least one expandable prosthesis 6 radiallyassociated with the expansion means 5 of said endolumenal device 1. Saidprosthesis comprises a tubular prosthesis body adaptable from a radiallycollapsed condition, of minimal external diameter, to a radiallyexpanded condition, of extended external diameter greater than thecollapsed external diameter.

For example, said kit for delivering and deploying an endolumenalexpandable prosthesis comprises at least one first radially expandableprosthesis associated with the proximal portion of the expansion meansof said endolumenal device and also comprises at least one secondradially expandable prosthesis associated with the distal portion of theexpansion means of said endolumenal device, or alternatively a singleprosthesis overlapping said proximal and distal portions of theexpansion means.

Each of the guidewires of said kit includes means of identification,such as for example the colour of at least a proximal portion of theguidewire, or a diameter of the cross section of a proximal portion ofthe guidewire which differs for each guidewire.

Said guidewires advantageously comprise an elastically flexible distalend portion.

In particular, said guidewires include initial proximal sections whichare positionable along a proximal section of path common to all theguidewires, and secondary distal sections which are positionable alongdistal sections of path which diverge and form with said proximalsection of path a bifurcation. It is particularly advantageous for atleast one of said guidewires to include an elastically flexible distalportion, which extends at least to straddle said bifurcation.

It is furthermore advantageous for said guidewires to includeradio-opaque markers, for example located near the tip of the distalportion.

A description of the working of an endolumenal device according to thisinvention follows.

In particular, the procedures necessary for guiding an endolumenaldevice along guidewires 24, 25 are described below. Said guidewires arelocated along a common proximal section of path and a diverging distalsection of path, forming a bifurcation between said sections. The abovemethod comprises the following stages:

-   -   said endolumenal device is fitted onto a proximal end of a first        guidewire so that said first guidewire is received in a first        guidewire lumen through its distal guidewire port;    -   said endolumenal device is fitted onto a proximal end of a        second guidewire so that said second guidewire is received in a        second guidewire lumen through its distal guidewire port;    -   said endolumenal device is advanced along said guidewires until        at least part of the distal end portion of the elongated body is        positioned beyond the bifurcation of the guidewires.

Advantageously, it is possible to envisage a further method of guidingan endolumenal device along guidewires 24, 25, in which said guidewiresare positioned along a common proximal section of path and a diverging,distal section of path, forming between said sections a bifurcation.This further method includes the following stages:

-   -   said endolumenal device is fitted onto a proximal end of a first        guidewire so that said first guidewire is received in a first        guidewire lumen through its distal guidewire port;    -   said endolumenal device is fitted onto a proximal end of a        second guidewire so that said second guidewire is received in a        second guidewire lumen through its distal guidewire port;    -   said endolumenal device is advanced along said guidewires until        at least part of the distal end portion of the elongated body        lies on a distal divergent section of path of one of the        guidewires.

The steps of a method for fitting radially expandable prostheses to thewalls of branches forming a ‘T bifurcation’ 32 are described below(FIGS. 12 to 17 e). Said bifurcation 32 comprises a main conduit 33 anda collateral conduit 34 that branches off from a wall of the mainconduit 33. The abovementioned method comprises the following steps:

A kit as described above, and in particular a kit which comprises anendolumenal device having a distal guidewire port located on a centralportion of the expansion means, is prepared.

Then, through a proximal section of the main conduit, a first guidewireis positioned in the main conduit so that it passes the bifurcation, anda second guidewire is positioned in the collateral conduit. Saidguidewires are positioned in such a way as to follow an initial proximalsection of path together and second distal sections of path that divergeat said bifurcation (FIG. 12).

Next, a first endolumenal device, equipped with a radially expandableprosthesis, is fitted onto a proximal end of the second guidewire, sothat said second guidewire is received in a guidewire lumen of theendolumenal device, through a distal guidewire port located on the tipof its elongated body.

Said first endolumenal device is inserted into said conduits followingthe proximal and then the distal sections of path of the secondguidewire in order to position the radially expandable prosthesis in thecollateral conduit so that its proximal edge is positioned near anostium of said collateral conduit (FIG. 13).

Said expandable means are then activated so that said prosthesis is inits radially expanded condition and fixed by pressure to the wall of thecollateral conduit (FIG. 14).

Next, said expansion means are withdrawn and the first endolumenaldevice is withdrawn from the second guidewire until it has been removedfrom the conduits.

A second endolumenal device equipped with a radially expandableprosthesis is fitted onto a proximal end of the first guidewire so thatsaid first guidewire is received in a first guidewire lumen through itsdistal guidewire port located on the tip of the endolumenal device. Saidsecond endolumenal device is fitted onto a proximal end of the secondguidewire so that said second guidewire is received in a secondguidewire lumen through its distal guidewire port located on the portionof elongated body that lies between a distal and a proximal end of theexpansion means.

Said endolumenal device is inserted into the main conduit and slid alongthe proximal section of path of the guidewires until a distal portion ofthe endolumenal device, located between the tip of said device and thedistal guidewire port of the second guidewire lumen, is positionedbeyond the bifurcation (FIG. 16).

The expandable means of said second device are activated so as to bringsaid prosthesis into its radially expanded condition and fixed bypressure to the wall of the main conduit and straddling the bifurcation(FIG. 17 a).

Finally said expansion means are withdrawn and then the secondendolumenal device is withdrawn from the guidewires until it has beenremoved from the conduits.

Further steps which make it possible to adapt the previously graftedprostheses in order to cover the lesion completely are described below.

A third endolumenal device without a prosthesis is fitted onto thesecond guidewire, positioning it to straddle the bifurcation so that adistal portion of the expansion means enters the collateral conduit anda proximal portion of the expansion means is positioned in the mainconduit.

The expansion means of the third device are then activated so as toadapt a portion of the prosthesis in the main conduit facing the ostiumor lateral window of the collateral conduit to the shape of the lumen ofsaid collateral conduit (FIG. 17 c).

Said expansion means are withdrawn and then the third endolumenal deviceis withdrawn from the second guidewire until it has been removed fromthe conduits.

By inflating the third endolumenal device (for example a ballooncatheter for angioplasty) straddling the bifurcation, the struts of theprosthesis grafted in the main conduit is moulded so that it surroundsthe ostium of the collateral conduit perfectly, and guarantees perfectcoverage of the lesion area (FIG. 17 c). Alternatively, particularly inthe case of larger diameter or larger bore conduits it is possible toinsert two balloon catheters simultaneously, fitting them on theguidewires 24, 25, so that they are paired and straddle the bifurcation,one in the main conduit and the second partially in the collateralconduit and partially in the main conduit. Simultaneous expansion of thetwo balloons shapes the prostheses so that they match and form acontinuous support structure which covers the entire extension of thelesion and creates, in the area of the bifurcation, a funnel-shaped areawhich joins the main and the collateral branches and promotesnon-vortical fluid flow in the conduits or vessels.

The stages of the method described above may also be reversed, graftingfirst the main vessel and then the collateral vessel.

In view of the above procedures it is evident that the grafting of aprosthesis in the main vessel shifts the plaque 39 material to obstructthe ostium of the collateral vessel or vice versa (FIG. 14). Thanks tothe fact that, using the device according to the invention, theapplication of a first prosthesis in a vessel is always carried outleaving a second guidewire in a second branch, in spite of the presencein the ostium of the same of a barrier of plaque caused by “snow-plow”or “plaque-shifting”. It is therefore always possible to insert in thesecond branch a device for the application of a second prosthesis. Usingknown prior-art devices it is not possible to operate simultaneouslywith two guidewires always present in the two branches of thebifurcation, because a second guidewire not positioned inside theprior-art device would be externally jailed by the prosthesis andrendered unusable. In other words, with the prior-art device it isnecessary to proceed using only one guidewire per procedural stage. Withthe device according to the invention, however, it is possible to effectthe swift exchange of the endolumenal device on guidewires which alwaysremain in situ, it being possible to withdraw the endolumenal devicefrom a first branch of the bifurcation to reinsert the same device or asecond device in a second branch with extreme rapidity.

The steps for a further method for fitting radially expandableprostheses to the walls of the branches of conduits forming a ‘Ybifurcation’ 35 are described below. Said bifurcation comprises aproximal main conduit 36 and a first and a second secondary distalconduits 37, 38 which branch off from a distal end of the main conduit,forming between them a carina. Said method comprises the followingsteps.

A kit as described above is prepared, and in particular a kit comprisingan endolumenal device fitted with a distal guidewire port located nearthe distal edge of a prosthesis fitted on the expansion means, and asecond distal guidewire port located at the tip of the device, or apicalport.

Through the main conduit first guidewire is positioned in the firstsecondary distal conduit and a second guidewire in the second secondarydistal conduit, said guidewires being positioned so as to follow a firstproximal section of path together and second distal section of path thatdiverge after said bifurcation (FIG. 18).

A first endolumenal device equipped with a radially expandableprosthesis is fitted onto a proximal end of the first guidewire, so thatsaid first guidewire is received in a guidewire lumen of the endolumenaldevice through its distal guidewire port located at the tip of itselongated body.

Said first endolumenal device is fitted onto a proximal end of thesecond guidewire so that said second guidewire is received in a secondguidewire lumen through its distal guidewire port located near theprosthesis distal edge, just beyond the prosthesis.

Said first endolumenal device is inserted into said conduits followingthe proximal section of path until the carina is positioned against theelongated body and near the distal guidewire port positioned near thedistal end of the expansion means (FIG. 19).

Said expandable means are activated so as to bring said prosthesis intoits radially expanded condition, fixed by pressure to the wall of themain conduit (FIG. 20).

Said expansion means are withdrawn and the first endolumenal device isthen withdrawn from the guidewires.

A second endolumenal device equipped with a radially expandableprosthesis is fitted onto a proximal end of the first guidewire so thatsaid guidewire is received in a guidewire lumen through its distalguidewire port located on the tip of said second endolumenal device.

A third endolumenal device equipped with a radially expandableprosthesis is fitted, at the same time as the second endolumenal device,onto a proximal end of the second guidewire so that said secondguidewire is received in a guidewire lumen through its distal guidewireport located on the tip of said third endolumenal device.

Said second and third endolumenal devices are simultaneously insertedinto the main conduit and slid along the proximal section of path of theguidewires and then along the respective distal sections of path of saidguidewires, until the expansion means are positioned in a proximalportion of said first and second secondary distal conduits, so that aproximal portion of the expansion means is positioned near the carina.In particular, care is taken to ensure that the proximal edge of boththe second and third prostheses is in contact with the distal edge ofthe first prosthesis, already positioned and expanded in the main lumen(FIG. 21).

The expansion means of said second and third endolumenal devices areactivated in order to bring the respective prostheses into a radiallyexpanded condition fixed by pressure to the walls of said first andsecond distal conduits (FIG. 22).

Said expansion means are withdrawn and then the second and thirdendolumenal devices are withdrawn from the guidewires until they havebeen removed from the conduits (FIG. 23).

The above description shows how the use of at least two guidewire lumenswhich extend at least partially along the inside of the elongated bodymakes it possible to fit the endolumenal device simultaneously on atleast two guidewires. In this manner, once at least two guidewires havebeen inserted in the branches of a bifurcation, it will be possible toinsert and withdraw the endolumenal device from a first branch of thebifurcation without ever loosing rapid access to all the branchesalready negotiated, i.e. reached by guidewires. In other words, it willbe possible to maintain uninterrupted access or vascular approach to allthe branches of the vascular system on which it is necessary to operateand in which a guidewire has been inserted or, in yet other words, usingthe device proposed it is no longer necessary to break through thebarrier of plaque 39 material which obstructs the ostium of the branchby “snow-plow” or “plaque-shifting”.

Thanks to the endolumenal device according to the invention it will alsobe possible to position accurately a first endovascular prosthesis inthe main vessel always with precise positioning and complete distensionor application of the prosthesis over the entire area of the lesion,thus reducing the probability of re-stenosis and avoiding the pitfallsof the known techniques.

Advantageously, the endolumenal device proposed allows extremeflexibility and modularity in the application of the endolumenalprostheses. Thus, if the expansion means are positioned exactlystraddling the bifurcation it is possible to deploy endolumenalprostheses of exactly the correct length and diameter for the dimensionsof the segment of damaged vessel to be treated, by means of the proximaland distal portions of the expansion means.

With further advantage, each portion of the expansion means makes itpossible to graft a number of endolumenal prostheses of optimal diameterand length for the anatomy of the damaged vascular branch.

When expansion means fitted to the endolumenal prostheses are in thecollapsed position, the device according to the invention is of reducedtransverse bulk, making it possible to reach peripheral branchesextremely easily and rapidly (trackability).

Together with the versatility of application of prostheses adapted todifferent branches of the bifurcation, the device proposed also makes itpossible to join prostheses, or, in other words, it allows totalcoverage of the damaged area, avoiding prolapse of atheromatous materialand reducing the probability of re-stenosis.

A further advantage derives from the fact that, using the endolumenaldevice according to the invention, the geometry of the prosthesis is notdistorted and the vascular anatomy is respected. In contrast, distortionof the prosthesis is inevitable when endolumenal devices according tothe prior art are used.

Obviously, variations and/or additions to what is described above andillustrated may be envisaged.

Alternatively to a balloon with rigid walls threefolded onto thecatheter body for insertion into the lumen of a vessel, as describedabove, it is possible to envisage the use of a compliant or extensibleballoon.

Other possible variations are:

-   -   the catheter of the type described above, “single-operator rapid        exchange” or “monorail”, may alternatively be of the        “over-the-wire” type, that is with opening of the proximal        guidewire lumens at the proximal end of the elongated body;    -   one of the at least two guidewire lumens may always be occupied        by a guidewire and may be inserted in the conduit, or vessel,        together with the endolumenal device. Preferably, in this case        the guidewire is fastened to or an integral part of the        elongated body of the endolumenal device, for example extending        from the apical portion of this (“fixed-wire”).    -   the catheter may also be of the perfusion balloon type in which        passages are provided for fluid flow when the balloon is        inflated: these provide communication between the portions of        elongated body above and below the expansion means (passages for        the blood in the body to prevent temporary occlusion of the        vessel during the application of the prosthesis and the        inflation of the balloon).    -   The endovascular prosthesis may be modular. For example it is        possible to provide a series of prostheses of set diameters and        a series of set lengths which the operator can crimp to the        proximal and distal portions of the expansion means, making them        extremely flexible or, in other words, making it possible to        adapt the prosthesis perfectly to the pathological requirements        of the moment, or in other words, to the size of the lesion and        the bore of the lumen of the vessel on which it is necessary to        operate.

As an alternative to the above description, illustrated by FIGS. 3 and8, at least one portion of said at least a couple of guidewire lumens12, 13 forms a single guidewire lumen (FIGS. 28, 29, 30, 33 and 34).

In a further variation of the invention, a guidewire lumen 13 havedistal ports 15 located near the proximal end of the expansion means, 5.Instead of the embodiment illustrated, for example, in FIGS. 2 or 3, theelongated body is attached externally to the wall of the balloon.

In a further embodiment of the invention, said expansion means aredesigned to hold a self-expanding prosthesis in a radially foldedposition and release it in a controlled manner so that it takes up aradially expanded position. Said expansion means include a sheathdesigned to receive in a sheath lumen said self-expanding prosthesis.Said sheath can advantageously be adapted in controlled manner from afirst constricted position in which the self-expanding prosthesis isconfined in said lumen of the sheath, to a second released position, inwhich said prosthesis is released from said lumen of the sheath so thatsaid prosthesis is radially free, to bring itself into the radiallyexpanded condition.

Such a device can be advantageously used in the artificial conduits ofbiomedical equipment that connects up to the patient's body. Forexample, a device of the type described above can be used fortransporting, positioning and deploying an element for the repair of thewalls of a conduit accidentally damaged during the use of theabovementioned machinery.

Advantageously, the endolumenal device 1 comprises at least a guidewirelumen 12 or 13 extended completely inside the elongated body 2.

With further advantage, the active portion of the expansion means isentirely associated to the elongated body in order to expand saidprosthesis exclusively from one side with respect to the elongated body,and in order to leave free from said expanded active portion the otherside of the elongated body.

According to one embodiment, the side of the elongated body portionassociated to the expansion means and free from said expanded activeportion, or free side, is provided with a fissure 100 suitable forrealizing a distal guidewire port 15 of the at least a guidewire lumen12, 13. It is furthermore advantageous for said fissure 100 to beextended between the distal end and the proximal end of the elongatedbody portion associated to the expansion means 5 (FIGS. 37, 38 and 39).

Preferably, the side of the elongated body associated to the expansionmeans 5 and free from the expanded expansion means comprises a wall 105that partially binds said at least a guidewire lumen 12,13. Said wall105 is suitable for being bored by a guidewire end 106, for example theproximal end, in order to slip said guidewire 24 through the boredportion of the wall 105 (FIG. 40).

According to a further embodiment, the at least a guidewire lumen 12and/or 13 of the tracking means has a plurality of distal guidewireports 14, 15, 15 ^(I), 15 ^(II), 15 ^(III), 15 ^(IV) and/or 15 ^(V), 15^(VI), 15 ^(VII), 15 ^(VIII), 15 ^(IX), 15 ^(X), 15 ^(XI), 15 ^(XII), 15^(XIII), 15 ^(XIV), spaced out along said elongated body 2 (FIGS. 31,32, 33, 34, 35 and 36).

Preferably, the guidewire tracking means 11 comprises a plurality ofguidewire lumens 12, 13, 13 ^(I), 13 ^(II), 13 ^(III) ssociated to eachof said distal guidewire ports 14, 15, 15 ^(I), 15 ^(II), 15 ^(III), 15^(IV) (FIGS. 31, 32).

Advantageously, the at least a guidewire lumen 12 and/or 13 has a distalguidewire port 14, or apical port, at the tip of said distal end portion3 of the elongated body 2 (FIGS. 31, 32, 33, 34, 35 and 36).

With further advantage, a first guidewire lumen 12 associated to saidapical port 14 is provided in the body and a second guidewire lumen 13is associated to a plurality of distal guidewire ports 15, 15 ^(I), 15^(II), 15 ^(III), 15 ^(IV); 15 ^(V), 15 ^(VI), 15 ^(VII), 15 ^(VIII), 15^(IX), 15 ^(X), 15 ^(XI), 15 ^(XII), 15 ^(XIV), or side ports, providedon a side of the elongated body opposite the expansion means (FIGS. 35and 36).

As an extremely advantageous alternative, a single guidewire lumen 12,13 associated to said apical port 14 is provided in the body and is alsoassociated to a plurality of distal guidewire ports 15, 15 ^(I), 15^(II), 15 ^(III), 15 ^(IV); 15 ^(V), 15 ^(VI), 15 ^(VII), 15 ^(VIII), 15^(IX), 15 ^(X), 15 ^(XI), 15 ^(XII), 15 ^(XIII), 15 ^(XIV), or sideports, provided on a side of the elongated body opposed to the expansionmeans (FIGS. 33 and 34).

In a further variation of the invention, the at least a guidewire lumen13 has a distal guidewire port 15 near a distal end of the expansionmeans 5.

Advantageously, the at least a guidewire lumen 13 has at least a distalport 15, 15 ^(I), 15 ^(II), 15 ^(III), 15 ^(IV); 15 ^(V), 15 ^(VI), 15^(VII), 15 ^(VIII), 15 ^(IX), 15 ^(X), 15 ^(XI), 15 ^(XII), 15 ^(XIII),15 ^(XIV) in a portion of the elongated body 2 that lies between adistal end and a proximal end of the expansion means 5.

In a further variation of the invention, the endolumenal device can beadvantageously used in order to improve maneuvrability and clinicalefficacy of some embolization containment devices (ECD) during coronaryangioplasty and stenting.

Actually, a frequent complication of these procedures is the so called“no-flow phenomenon”, consisting of impairment of the blood to flow downto the distal vessels, even though the obstruction has been removed.

This calamitous event is mainly caused by the distal embolization of thethrombus debris, and arterial spasms induced by some vaso-constrictivesubstances released into the blood stream because of the plaquecrumbling and compression during balloon inflation.

These events are frequent when treating recent coronary occlusions inacute myocardial infarction, or when treating coronary lesions withangiographic evidence of a thrombus within the lumen, as in unstableangina.

Therefore, in addition to bifurcated lesion treatment, the proposeddevice will find large scale application in the situations as describedhere following.

Most ECD currently in use take the form of an occluding balloon 102(FIG. 42 b), or of a basket-shaped or an umbrella-shaped device 101(FIG. 42 c), which necessarily blocks the flow distally of debris, andsubstances which can cause vasospasms.

An example of such application is described with the following steps:

Step 1—a conventional guidewire (cGW) 24 is advanced beyond theocclusion as a “trailblazer” for the ECD 101. In fact, these deviceshave less maneuvrability and are more fragile than cGW 24 and,therefore, can't be used to bore, and to cross an occlusive thrombus(FIG. 41).

Step 2—the ECD 101 is positioned as proximal as possible, butsufficiently distant to permit the entrapment of the embolic materialand to allow easy handling and positioning of a stent-delivery system,and finally, stent deployment. Furthermore, positioning must be withoutexcessive advancement of the ECD which would allow embolic material toescape into lateral branches 34, if positioned beyond vesselbifurcations.

Step 3—the ECD 101 is activated (i.e., the “umbrella” is opened or the“balloon” inflated), after which the cGW is withdrawn, in order to avoidits jailing between the stent and the vessel wall after stent deployment(FIG. 42 a).

Step 4—a conventional stent-delivery system is advanced using the ECD101 as a guidewire (FIG. 43).

Step 5—the stent-delivery system is inflated and the stent deployed(FIG. 44).

Step 6—debris and vasospastic substances, released during the stentingprocedure, and entrapped by the ECD, are removed: with suction using adedicated probe which has been advanced until it is contiguous with theocclusive “balloon”, or withdrawn within the “umbrella”, after itsclosure (FIG. 45).

As clearly described, this technique presents some drawbacks:

-   -   ECD 101, used as guidewire, give low support to the delivery        systems especially when they are positioned very proximally;    -   a guidewire 24 repositioning could be needed after the stent        deployment because of procedural complications (such as        dissections) or in order to treat other lesions which come to        light only after they has been reopened. This procedure takes        time and can be hazardous and unsuccessful.

Therefore, leaving the guidewire 24 for the duration of the procedurewould be preferable.

All of this is easily performed with the proposed device 1 which allowsto ride both a cGW 24 (represented with a broken line in FIGS. 43, 44and 45) and a ECD 101 or 102 simultaneously, utilizing the apical port14 and a lateral or side port 15 provided on a side of the elongatedbody of the expansion means 5 (FIGS. 35,36).

Therefore, we can leave a distally positioned cGW 24 for the duration ofthe procedure, as an “auxiliary wire” to give more support to thedelivery system and to avoid re-crossing the stented lesion, should thisbecome necessary.

This proposed device also offers a significant clinical advantage in thetreatment of a thrombotic occlusion involving the ostium of a branch, orjust proximal to a vessel bifurcation (very frequent cases), as shown inthe following steps:

Step 1—the occlusion is crossed using a cGW 24 as a “trailblazer” (FIG.46);

Step 2—a first ECD 101 is advanced into a first branch 37 (FIG. 47);

step 3—a second ECD 101 is advanced into a second branch 38, and bothECD are activated after the cGW 24 withdrawal (FIG. 48);

step 4—the proposed stent-delivery device 1 is advanced and positionedwith the simultaneous use of both ECD's as guidewires (FIG. 49);

step 5—the stent is deployed and the vessel patency and the blood flowrestored (FIG. 50);

step 6—the debris and any substance released during the procedure,entrapped by the 2 ECD's, are finally removed (FIG. 51).

Further clinical condition, where the device is extremely useful, is inan ostial lesion at the origin of the right coronary artery or asaphenous graft. In this case the engagement of a guidecatheter 103 isimpossible due to the narrowing of the lumen. Therefore theguidecatheter 103 is positioned free in the middle of the aortic lumen,opposite the ostium, where there are a continual cardiac-cycle relatedmovements of both the guidecatheter 103 and the delivery system 1.

In such circumstances the stent positioning and deployment, using theknown devices, is necessarily imprecise and may improperly be implanted,or may be the cause of failure of the procedure. So, often times, theseclinical situations are referred to surgeon for aorto-coronary bypassgrafting.

Utilising the proposed device 1, it is possible to attain a precisepositioning and deployment. The proposed method comprises: positioningof a first guidewire 24 in the diseased vessel suitable to fit it in theapical port 14 of a proposed device guidewire lumen; then positioning ofa second guidewire 25 free in the aortic lumen and fitting said freeguidewire in a proposed device side port 15 ^(XIV), just proximal to astent 6 crimped down on the delivery system. In this way, the proposeddevice 1 can be advanced in the right coronary artery until the emergingsecond guidewire 25 blocks the delivery system with the proximal edge ofthe stent 6 perfectly aligned with the aortic wall. By maintaining aconstant, even push until the stent delivery system (balloon) isactivated (inflated), it is possible to attain a stable positioningwithin the ostial lesion and, therefore, the proper deployment of astent.

A further method of employment of the proposed device is in the stentingof bifurcated lesions, where the proposed device 1 allows the operatorto implant simultaneously two stents 6 ^(I) and 6 ^(II), perfectlyflanked with their proximal edges on the same level, utilizing a known“V” or “kissing” technique.

After having positioned guidewires 24, 25 in the respective branches 37and 38, a first guidewire 24 is fitted in a first device through itsapical port 14.

The same guidewire exits the device through a side port 15 ^(XIV),proximal to the stent, and the first device is then advanced in thefirst branch 37 (FIG. 53).

A second guidewire 25 is received in a second device through its apicalport 14. The first guidewire 24, received in the first device, issubsequently fitted in the second device through its side port 15 ^(XIV)proximal to the stent (FIG. 54).

This second device is then advanced until it is “automatically” blockedwhen its side port 15 ^(XIV) arrives at vessel bifurcation, where thetwo guidewires 24, 25 diverge. With a gentle pulling back of the firstdevice, the respective side ports 15 ^(XIV) will be perfectly alignedand held in position by the first guidewire 24, which exits the firstdevice and re-enters the second device.

In this way, the stents 6 ^(I) and 6 ^(II), mounted on two devices willnecessarily be positioned with the proximal stent edges at the samelevel and with a complete coverage of the vascular “carina” between thetwo branches (FIG. 55).

Contrary to the “V” and “kissing” technique used with traditionalballoons, the proposed device allows an “automatic” and precisepositioning of paired stents, avoiding approximations, or that one ofthe two delivery systems is dislodged by the other during inflation ofthe balloons.

The proposed method of deployment is extremely efficient, particularlyif employed subsequently a preliminary deployment of a stent 6 in theparent vessel, just proximal to the bifurcation; or implanting in thetwo branches dedicated stents having proximal-angled edges. In this waythe coverage of the lesion is improved, avoiding overlapping of thestents, and with a complete coverage of the plaque (FIG. 55).

It is a further advantage that the proposed device has the possibilityto rotate in a controlled manner along its longitudinal axis. In thisway it is possible to properly orient and deploy stents. Thus, evenwithout a bifurcated lesion, with a guidewire 24 previously deployed ina side-branch (i.e. in a septal or diagonal branch) it is possible toimplant dedicated stents 103 with variable structures along theircircumference (i.e.: struts 104, 105 of variable widths or withdifferent drug coatings 106, and cells, with different diameter ordimensions, provided in different region of the stent) thereby allowinga specific treatment of selected areas in a single lesion.

A person skilled in the art could make numerous changes and adaptationsto the preferred embodiment of the endolumenal device described above orsubstitute elements with others functionally equivalent, in order tomeet contingent and specific requirements, without however departingfrom the scope of the following claims.

1. Endolumenal device for delivering and deploying an endolumenalexpandable prosthesis at a bifurcation provided with a main conduit andat least a secondary conduit, comprising: an elongated body having aproximal end portion and a distal end portion; the distal end portion ofsaid elongated body comprising an expandable portion having a proximalend and a distal end, the expandable portion engageable with theendolumenal expandable prosthesis and adapted to adjust said prosthesisfrom a radially collapsed condition to a radially expanded condition; aguidewire tracking device at least partially extending along saidelongated body; wherein said expandable portion being longitudinallyassociated to the elongated body in order to expand said prosthesiseccentrically from one side with respect to the elongated body, and saidguidewire tracking device comprises at least a guidewire lumen at leastpartially extending inside said elongated body, having a plurality ofguidewire distal ports comprising a first guidewire distal port and asecond guidewire distal port, the first guidewire distal port and thesecond guidewire distal port being in communication with the same lumenand opening to an outside of the endolumenal device to be in fluidcommunication with a blood vessel in use, said first guidewire distalport provided on a side of the elongated body opposed to the expandableportion and suitable for slipping through it a guidewire portion of atleast a guidewire placeable with its distal portion in said main or atleast a secondary conduit, said second guidewire distal port provided ona side of the elongated body opposed to the expandable portion forslipping through it a guidewire portion; wherein each of the firstguidewire distal port and the second guidewire distal port is locatedbetween the proximal end and distal end of the expandable portion. 2.Endolumenal device according to claim 1, in which said at least aguidewire lumen extends completely inside said elongated body. 3.Endolumenal device according to claim 1, in which said expandableportion is entirely associated to the elongated body in order to expandsaid prosthesis exclusively from one side with respect to the elongatedbody and in order to leave free from said expanded expandable portionthe other side of the elongated body.
 4. Endolumenal device according toclaim 1, in which the side of the elongated body portion associated tothe expandable portion and free from said expanded expandable portion isprovided with a fissure suitable for forming a distal guidewire port ofsaid at least a guidewire lumen.
 5. Endolumenal device according toclaim 4, in which said fissure is extended between a distal end and aproximal end of said elongated body portion associated to the expandableportion.
 6. Endolumenal device according to claim 1, in which the sideof the elongated body associated to the expandable portion and free fromthe expanded expandable portion comprises a wall that partially boundssaid at least a guidewire lumen and is suitable for being bored by aguidewire end in order to slip through the bored portion of the wallsaid guidewire.
 7. Endolumenal device according to claim 1, in whichsaid at least a guidewire lumen has a plurality of distal guidewireports spaced out along said elongated body.
 8. Endolumenal deviceaccording to claim 7, in which said guidewire tracking device comprise aplurality of guidewire lumens at least one of which is associated toboth of said distal guidewire ports.
 9. Endolumenal device according toclaim 1, in which the guidewire lumen has a distal apical guidewire portat the tip of said distal end portion of the elongated body. 10.Endolumenal device according to claim 9, in which the guidewire trackingdevice further comprises a first guidewire lumen and a second guidewirelumen, at least one of said first guidewire lumen and said secondguidewire lumen being associated to a plurality of distal guidewireports, or side ports, provided on a side of the elongated body opposedto the expandable portion.
 11. Endolumenal device according to claim 9,in which the guidewire tracking device comprises a single guidewirelumen associated to said apical port.
 12. Endolumenal device accordingto claim 1, in which the first distal guidewire port is located near adistal end of the expandable portion.
 13. Endolumenal device accordingto claim 1, in which the at least a guidewire lumen has at least aproximal guidewire port provided in a portion of the elongated bodylocated, with respect to the expandable portion, at the opposite endfrom its distal end.
 14. Endolumenal device according to claim 13, inwhich the elongated body includes radio-opaque markers for theidentification of the position along said body of the distal and/orproximal guidewire ports of the guidewire lumen.
 15. Endolumenal deviceaccording to claim 1, in which the second distal guidewire port islocated near a proximal end of the expandab1e portion.
 16. Endolumenaldevice according to claim 1, in which said expandable portion is aballoon.
 17. Endolumenal device according to claim 16, in which saidballoon is functionally connected to an inflation lumen extendingbetween the proximal and distal end portions of the elongated body. 18.Endolumenal device according to claim 17, in which the proximal endportion of the elongated body comprises a fluid connector, which is influid communication with the inflation lumen and which is adapted tofunctionally couple with a pressurizable fluid source.
 19. Endolumenaldevice according to claim 18, in which said balloon, under the effect ofthe pressurized fluid, is expandable eccentrically from one side orlaterally with respect to the elongated body in order to leave free fromsaid expanded balloon the other side of the elongated body. 20.Endolumenal device according to claim 19, in which said balloon is incontact with the elongated body between its distal end and its proximalend.
 21. Endolumenal device according to claim 20, in which the entireportion of the elongated body associated to the balloon is attachedinternally to the wall of the balloon.
 22. Endolumenal device accordingto claim 21, in which the entire portion of the elongated bodyassociated to the balloon is attached externally to the wall of theballoon.
 23. Endolumenal device according to claim 1, in which theelongated body includes radio-opaque markers for the identification ofthe position along said body of the first and second guidewire distalports of the at least a guidewire lumen.
 24. Endolumenal deviceaccording to claim 1, in which the elongated body includes radio-opaquemarkers for the identification of the position along said body of adistal and/or proximal end of the expandable portion.
 25. Endolumenaldevice according to claim 1, in which said expandable portion issuitable for holding a self-expanding prosthesis in a radially collapsedposition and releasing it in a controlled manner so that it assumes aradially expanded position.
 26. Endolumenal device according to claim 1,wherein said plurality of guidewire distal ports comprises a thirdguidewire distal port located on a side of the elongated body opposed tothe expandable portion.
 27. Endolumenal device according to claim 26,wherein the third guidewire distal port is located between the first andsecond guidewire distal ports.
 28. Endolumenal device according to claim1, wherein said plurality of guidewire distal ports consists of only twoguidewire distal ports.
 29. Endolumenal device according to claim 1,wherein the endolumenal device is configured to prevent advancement ofsubstantially all of the expandable portion distal to the bifurcationwhen the first guidewire port is advanced to the bifurcation over aguidewire portion.
 30. Endolumenal device for delivering and deployingan endolumenal expandable prosthesis at a bifurcation provided with amain conduit and at least a secondary conduit, comprising: an elongatedbody having a proximal end portion and a distal end portion; the distalend portion of said elongated body comprising an expansion device havinga proximal extremity, a distal extremity, and a longitudinally extendedactive portion comprising a prosthesis attachment region removablyengageable with the endolumenal expandable prosthesis and adapted toadjust said prosthesis from a radially collapsed condition to a radiallyexpanded condition said expansion device comprising a distal end and aproximal end; a guidewire tracking device at least partially extendingalong said elongated body; wherein said active portion of the expansiondevice is longitudinally associated to the elongated body in order toexpand said prosthesis eccentrically from one side with respect to theelongated body, in order to leave free from said expanded active portionthe other side of the elongated body, and said guidewire tracking devicecomprises at least a guidewire lumen at least partially extending insidesaid elongated body, having at least three guidewire distal portsincluding a first guidewire distal port provided on a side of theelongated body distal of the prosthesis attachment region of theexpansion device and near a distal end of the expansion device andopposed to the expansion device and suitable for slipping through it aguidewire portion of at least a guidewire placeable with its distalportion in said main or at least a secondary conduit, said guidewiretracking device also having a second guidewire distal port provided on aside of the elongated body proximal of the prosthesis attachment regionof the expansion device and near a proximal end of the expansion devicefor slipping through it a guidewire portion; said guidewire trackingdevice also having a third guidewire distal port provided on a side ofthe elongated body for slipping through it a guidewire portion, thethird distal guidewire port being located between the first and seconddistal guidewire ports; wherein each of the first guidewire distal port,the second guidewire distal port, and the third guidewire distal port islocated between the proximal extremity and the distal extremity of theexpansion device, and said first guidewire distal port, said secondguidewire distal port, and said third guidewire distal port communicatewith a single guidewire lumen; and wherein the endolumenal device isconfigured to prevent advancement of substantially all of the expansiondevice distal to the bifurcation when the first guidewire port isadvanced to the bifurcation over a guidewire portion.
 31. Endolumenaldevice according to claim 30, in which the guidewire lumen has a distalapical port.
 32. Endolumenal device according to claim 30, in which theelongate body has a proximal end and further comprises proximal sideports positioned in the portion of the elongated body that lies betweenits proximal end and the expansion device.
 33. Endolumenal device fordelivering an endolumenal expandable prosthesis at a bifurcationprovided with a main conduit and at least a secondary conduit,comprising: an elongated body having a proximal end portion and a distalend portion, the distal end portion of said elongated body comprising anexpandable portion having a proximal end and a distal end, theexpandable portion being engageable with the endolumenal expandableprosthesis and adapted to adjust said prosthesis from a radiallycollapsed condition to a radially expanded condition; a guidewiretracking device at least partially extending along said elongated body,said guidewire tracking device comprising at least one guidewire lumenhaving a central longitudinal axis and a plurality of guidewire portsopening from the lumen to an outside of the endolumenal device tocommunicate with a blood vessel in use, said guidewire ports suitablefor slipping therethrough a guidewire placeable with its distal portionin said main or at least a secondary conduit, said expandable portionbeing disposed on one side of the central longitudinal axis of the lumenand the plurality of guidewire ports are disposed on another side of thelongitudinal axis opposite the expandable portion; and wherein at leasttwo of the guidewire ports are located between the proximal and distalends of the expandable portion.
 34. The endolumenal device of claim 33,whererin the guidewire tracking device comprises a first lumen and asecond lumen for advancement of a guidewire distal of the bifurcation inuse.
 35. The endolumenal device of claim 34, wherein the second lumenextends proximally from an apical port located at the distal end of theelongate body.
 36. The endolumenal device of claim 34, wherein thesecond lumen extends entirely within the elongate body from a distalportion of the elongate body to a proximal end thereof.
 37. Theendolumenal device of claim 34, wherein the expandable portion and thesecond lumen are positioned on the same side of the central longitudinalaxis of the first lumen.